The Bio-Process Systems Alliance (BPSA) was formed in 2005 to encourage the adoption of single-use manufacturing technologies in biopharmaceutical and vaccine production. Kevin Ott, executive director of BPSA, shared his thoughts with the Pharmaceutical Sciences, Manufacturing & Marketplace Report, about the latest trends and issues surrounding single-use technologies and the role of his association.

Gains in adopting single-use technologiesPharmaceutical Sciences, Manufacturing & Marketplace Report: What were major positive developments for single-use technologies in 2012?

Ott (BPSA): There is increased and ongoing interest, as exhibited by the influx of pharmaceutical manufacturers into the BPSA, in adopting single-use systems in drug and vaccine manufacture, as well as in fill–finish operations. This interest is, in part, being driven by the move towards “ personalized medicines,” where it is important to fit the production facility to the production needs to fulfill drug demands for smaller patient populations versus a “ blockbuster” drug.

The appeal of single-use in drug production is the reduced risk of contamination, reduced costs and scheduling, operational efficiency, and reduced capital expenditures, both from a fixed-facility investment standpoint and a consumables standpoint. The positive development here is that “ single-use” or “ disposables” are being seen less and less as “ just” tools for the biotech industry, but more and more as accepted, viable alternatives for pharmaceutical and vaccine production.

Challenges in single-use technologiesPharmaceutical Sciences, Manufacturing & Marketplace Report: What were major challenges/hurdles for single-use technologies in 2012?

Ott (BPSA): If you would have posed that question as recently as three years ago, the answer would have decidedly been concerns from the user base with extractables and leachables (E&Ls). But, it appears that there is a sense now that the “ problem” of E&Ls is morphing into one of how to best manage the risk. Through thorough vetting of this issue by the supplier side of the industry via, for example the BPSA Recommendations for Testing and Evaluation of Extractables from Single-Use Process Equipment (BPSA 2010), we have seen concerns allayed in the user arena as test methods can now be standardized to an extent that allows for comparative results vis-à-vis stainless steel.

Some of the current concerns with end users in the universe of disposable bio-processing are now system robustness, particulates in solution (visible or invisible) and end-of-life disposal of the plastic. BPSA is addressing these issues through its End User Committee, which is actively engaged in technical document development and forums on these matters, and led by several larger biopharmaceutical manufacturers in tandem with the extensive component and system supplier base that comprises the broad BPSA corporate membership roster.

Key trends and outlook for 2013Pharmaceutical Sciences, Manufacturing & Marketplace Report: What do you see as the general trends and issues for single-use technology for biopharmaceutical manufacturing and what will their impact be in 2013?

Ott (BPSA): We recognize both “ big-picture” and “ lower-level” aspects in the pharmaceutical business that will drive demand for single-use, such as demographics, healthcare reform, pandemic response, government’s role in healthcare delivery, military needs, even the ability of Medicare, for example, to pay for expensive therapies in an era of huge budget deficits. On the “ lower level,” concerns, such as supplier lead times and quality responsibilities, standardization of systems (plug and play), best practices, the aforementioned particulate and durability issues, and the ultimate comfort level with disposable plastic containers that might hold a million dollars worth of drug product in a 5-mL flexible container are all concerns to users, and should be.

However, these general trends will be augmented by a clearer understanding of both the high utility of single-use as well as the concurrent (present day) technological limits of single-use in biopharmaceutical manufacture. Stainless-steel systems will never be fully replaced by single-use. But, business trends and economic demands will likely move more manufacturers into plastic. Competition demands it.

Other trends in 2013 will be a continued focus on the “ factory of the future,” such as Shire’s in Lexington, Massachusetts, which pushes single-use in evolutionary ways and underscores the importance of operator training. Are we educating “ hands-on” technicians in plastics? Are we adequately training personnel?

There are also many questions about the future. Will plastic components remain inexpensive enough to throw away? How can facilities be designed specifically to product and patient needs? Can we quantify the “ green benefits” of single-se? What will happen to raw material prices with the advent of cheap shale gas? Will advances in DNA profiling and stem-cell research drive demand for boutique drugs targeted at “ orphan” patient populations, demanding small-scale manufacture?

All of these “ externalities” may impact Single-Use in 2013 and beyond, but it is evident that the “ raging incrementalism” that has brought Single-Use to the business forefront will continue in this decade.

Ott (BPSA): All of the “ big-picture” and “ lower-level” aspects have been addressed, or are being addressed, either in working committees of BPSA or at its annual eetings. Context here is key; technology always lives within the scope of market demands, pricing, efficacy of use, and in some cases, government regulation.

From Day One, BPSA has served as the focal point for accelerating the adoption of single-use in both the clinical pipeline and at commercial scale, including upstream and downstream. To that end, BPSA has been actively filling the gap with technical deliverables in the form of GMP guides and by educating a variety of audiences on the critical business aspects of single-use adoption. The bottom line is that BPSA’s core activities are targeted at safeguarding the quality of drugs and therapies produced with plastics-based technologies and platforms.

BSPA’s targets for 2013Pharmaceutical Sciences, Manufacturing & Marketplace Report: What does BPSA have planned for 2013?

Ott (BPSA): There are several significant projects on the BPSA agenda for 2013, all driven by member participation:

The issuance of a BPSA Quality Template Agreement to help suppliers and customers build a contractual relationship based on common terms and responsibilities

The revision and re-issue of our BPSA Component Quality Test Matrices Technical Guide from 2007 to identify consensus quality tests for film and containers, sensors, connectors, fittings, and tubing

An in-process deliverable by 2014 that will identify, qualify, and address particulates in final drug products

A continuing education series for FDA about single-use systems;

A continuing dialogue with industry, both user and supplier, on system and component standardization and harmonization; and

The 2013 (3rd Annual) International Single-Use Summit (ISUS) to be held in Washington, DC July 15-17, 2013.